Your initial statement, "Under MDR, the manufacturer shall conduct clinical evaluation for all the Class I medical devices" leaves out an important exception.
Start with the EU-MDR Annex I and determine which requirements apply to your device. For those that apply, determine how you intend to demonstrate conformity. There are many methods available; one is clinical data.
For the clinical evaluation plan, go to Article XIV, Part A, Section 1(a), first indent which asks for "an identification of the general safety and performance requirements that require support from relevant clinical data". Look back at your Annex I conformity demonstration decisions. If there are any that require clinical data, then continue with clinical evaluation. If there are not any, then go to Article 61(10) which covers the case "where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate".
Write the justification and put it in Annex II(6.1)(c).
For low risk devices in general and, I think your device in particular, it is unlikely that you would need clinical data to demonstrate Annex I conformity. Consequently, you do not need clinical evaluation.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 02-Jan-2020 12:24
From: Anonymous Member
Subject: Clinical Evaluation under MDR
This message was posted by a user wishing to remain anonymous
Dear All,
We have a medical device - Class I (under MDR), used as an accessory of our IVD device. it must be used with the IVD device in order to perform the test as intended.
Under MDR, the manufacturer shall conduct clinical evaluation for all the Class I medical devices. Do we need to have a separate clinical evaluation for this Class I medical device or we can combine it in the performance evaluation for IVD device under IVDR?
Thank you.